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FDA 510(k)

TD-7301 Spirometer (TD-7301)

K-Number: K241843 · 2024-11-20

ApplicantGostar Co., Ltd.
Decision Date2024-11-20
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TD-7301 Spirometer (TD-7301) is the device name listed in this FDA 510(k) record. The listed applicant is Gostar Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K241843. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TD-7301 Spirometer (TD-7301)?

TD-7301 Spirometer (TD-7301) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Gostar Co., Ltd.. The 510(k) number is K241843.

When did TD-7301 Spirometer (TD-7301) receive FDA 510(k) clearance?

TD-7301 Spirometer (TD-7301) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K241843.

Who is the listed applicant for TD-7301 Spirometer (TD-7301)?

The FDA 510(k) record lists Gostar Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TD-7301 Spirometer (TD-7301)?

The FDA product code for TD-7301 Spirometer (TD-7301) is BZG.

Other records listing Gostar Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222810TD-7301 Peak Flow meterK221419TD-5010 Lancing Device and TD-5084 Sterile Lancets

Related Devices (Code: BZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251777MESI mTABLET SPIROMesi D.O.O.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private LimitedK222443Air Smart Extra SpirometerFeellife Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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